We have blogged before (see here and here) about the steps initiated in mid-2018 by the Trump EPA to weaken new chemical reviews under the Toxic Substances Control Act (TSCA) – rendering them even less health-protective than under TSCA prior to the 2016 reforms enacted in the Lautenberg Act.

As these debilitating policy changes – still never publicly described or released, and apparently still not written down even for use within EPA – have taken hold, we have seen dozens of flawed new chemical decisions emerge. We blogged extensively about the first such decision made under the new regimen in late July 2018. Since then, about 60 more final determinations reflecting the new policies have been posted on EPA’s website. These decisions pertain mostly to premanufacture notifications (PMNs), along with a few for significant new use notices (SNUNs). At least 80% of these chemicals were cleared to enter commerce without being subject to any conditions whatsoever. EPA accomplished this by issuing a final determination that each cleared chemical, or significant new use of a chemical, is “not likely to present an unreasonable risk.” For these determinations, EPA is required under TSCA to post a statement of its finding, which it does in another table on its website.

We have been closely examining these “not likely” determination documents. Some deeply disturbing patterns are emerging. This post will describe one of them.

A new addition to the long and growing list of illegal actions EPA has taken to render the new chemicals program weaker than under the old TSCA.

Most striking is that for a significant majority of these chemicals, EPA either identified significant risks to workers or indicated it had insufficient information to determine the level of risk to workers. Under the 2016 reforms to TSCA, either finding – that there are or may be risks or that there is insufficient information to determine the level of risk – requires EPA to issue an order specifying conditions sufficient to eliminate the risk. Yet EPA did no such thing; instead, it cleared the chemicals for unfettered market access.

Hazards posed to workers

It is not as if these chemicals are inherently benign; indeed, EPA identified significant hazards for many of them. In the summary of EPA’s “not likely” determination document for PMN P-18-0221, the agency states that it identified the “potential for the following human health hazards: skin and lung sensitization, mutagenicity, carcinogenicity, and developmental, reproductive, liver, and kidney toxicity.” Yet the very next sentence states: “EPA concludes that the new chemical substance is not likely to present an unreasonable risk under the conditions of use.”

Here’s another example, the “not likely” determination document for PMN P-18-0324. EPA identified “potential for the following human health hazards: lung toxicity (waterproofing), irritation, neurotoxicity and developmental toxicity.” Yet, again, “EPA concludes that the new chemical substance is not likely to present an unreasonable risk under the conditions of use.”

Risks posed to workers

In both of these cases, as in many others, EPA also identified risks to workers from these same hazards, with predicted exposures well in excess of “safe” levels.

So how does EPA make these risks to workers magically disappear – without imposing a single condition on such chemicals? By simply “expecting” them out of existence. All of these “not likely” determination documents include a sentence like this (emphases added):

EPA expects that workers will use appropriate personal protective equipment (i.e., impervious gloves), consistent with the Safety Data Sheet prepared by the PMN submitter, in a manner adequate to protect them.

There are so many things wrong with this. Here are some:

Reliance on nonbinding documents: EPA provides absolutely no evidence to support its “expectation.” It simply assumes that all workers coming into contact with the chemical will always “use appropriate personal protective equipment” (PPE) because the company submitting the PMN for the chemical has prepared a safety data sheet (SDS) recommending its use. But SDSs impose no binding requirements either on employers or their employees to do so. The mere presence of language in an SDS is completely insufficient to conclude that PPE is actually utilized or is sufficiently effective and protective. While SDSs are required to be provided as a hazard communication tool, the only legal requirement under OSHA is that the employer provide the SDS to employees and train them on how to access and understand them. For example, the 2012 OSHA Hazard Communications Standard explains (emphases added):

While the current HCS [Hazard Communication Standard] and this final standard require the provision of information on recommended control measures, including respiratory protection, personal protective equipment, and engineering controls, there is no requirement for employers to implement the recommended controls. An employer should use all available information when designing an appropriate protective program, but a recommendation on a safety data sheet by itself would not trigger the need to implement new controls.

Any legal requirement under OSHA that SDS recommendations be followed would come through a separate requirement such as where there is an OSHA exposure limit for the substance. For new chemicals, for which OSHA obviously has no such standards, there is no OSHA obligation beyond OSHA’s rarely used general duty clause for employers to provide any protection for workers.

Even companies’ own SDSs acknowledge this reality, including when it comes to an SDS that accompanies a chemical as it moves downstream to other processors and users. For example, the SDS for PMN P-18-0070 states that the manufacturer:

assume[s] no responsibility regarding the suitability of this information for the user’s intended purposes or for the consequences of this use. Individuals should make a determination as to the suitability of the information for the particular purpose(s).

Despite these limitations of SDSs, EPA simply assumes, with no actual evidence, that there will be 100% use and efficacy of the PPE specified in a SDS by all workers throughout a chemical’s supply chain.

It’s also worth noting EPA has erected major barriers to the public gaining access to the SDSs companies submit with their PMNs. We have blogged extensively about EPA’s failure to provide ready access to PMN public files, which include SDSs. Moreover, even once we gain such access, SDSs are often heavily or wholly redacted based on illegal claims – apparently unreviewed by EPA and hence allowed to stand – that they constitute confidential marketing and sales information protected from disclosure.

Reliance on ineffective nonbinding documents: There is significant evidence that SDSs are frequently not understood or followed. For example, one recent systematic search and review of the literature identified serious problems with the use of SDSs even as hazard communication tools: they are often inaccurate, incomplete, and too technical for workers to understand. The 2012 OSHA Hazard Communications Standard corroborates these findings. For example, the Standard reports that “several studies show that employees do not understand approximately one-third of the safety and health information listed on SDSs prepared in accordance with the current standard” and that “[s]tudies also report that roughly 40% of persons reviewing SDSs found them difficult to understand.” Also, see OSHA’s Inspection Procedures for the Hazard Communication Standard for more on the limitations of SDSs.

Reliance on ineffective methods specified in ineffective nonbinding documents: Reliance on PPE has major practical limitations and, at best, exhibits mixed effectiveness in the real world. For example, OSHA concluded that respirators are the “least satisfactory approach to exposure control.” The agency provides the following explanation:

[T]o be effective, respirators must be individually selected, fitted and periodically refitted, conscientiously and properly worn, regularly maintained, and replaced as necessary. The absence of any one of these conditions can reduce or eliminate the protection the respirator provides.

Respirator effectiveness ultimately relies on the practices of individual workers who must wear them. … Furthermore, respirators can impose substantial physiological burdens on workers, including the burden imposed by the weight of the respirator; increased breathing resistance during operation; limitations on auditory, visual, and olfactory sensations; and isolation from the workplace environment.

OSHA therefore continues to consider the use of respirators to be the least satisfactory approach to exposure control … .

Yet EPA relies solely on PPE identified in the SDSs as the basis for asserting that unreasonable risks to workers will be eliminated.

Failure to rely on the best available science and policy: EPA’s reflexive impulse to resort to reliance on PPE fails to reflect the best available science and policy. The best available science and policy have long been memorialized through OSHA’s Industrial Hygiene Hierarchy of Controls (HOC), which prioritizes measures to eliminate or reduce the presence of a hazard in occupational settings (e.g., substitution/use of less toxic chemicals and institution of engineering controls) over measures like PPE that shift burdens onto the workers themselves. The HOC, not PPE, exemplifies the best available science and policy for creating safe, healthful workplace environments.

Unfortunately, EPA has not finalized the proposed modifications to its SNUR regulations. While EPA had been incorporating language reflecting the HOC into consent orders it was issuing for new chemicals, it now appears EPA is abandoning reliance on the HOC altogether, both by failing to issue orders and basing its “not likely” determinations on assumed use of PPE.

The 2016 amendments to TSCA enhanced EPA’s obligations to protect workers, obligations that date back to the original law passed in 1976. TSCA now explicitly defines workers to be a “potentially exposed or susceptible subpopulation.” And it specifically requires EPA to identify, assess and mitigate unreasonable risks to workers.

EPA appears at least in limited ways to be identifying risks to workers posed by new chemicals. But when it comes to actually protecting them from such risks – which would require imposing binding requirements on companies – that’s when workers get thrown under the bus. If EPA’s toxics office were serious about environmental justice as a priority under TSCA, as it has recently asserted it is with respect to workers exposed to pesticides, it would not so casually cast aside risks to workers from new chemicals.

Add this to the long and growing list of illegal actions EPA has taken to render the new chemicals program weaker than under the old TSCA.

In January 2018, US Food and Drug Administration (FDA) scientists published a peer-reviewed journal article stating a commonly used raw material to make greaseproof paper is likely to persist in the human body. FDA scientists’ sophisticated analysis and remarkable conclusion raises questions about the broad assumption that short-chain perfluorinated alkyl substances (PFAS), as a class, did not accumulate.

Strangely, tworecent reviews funded by the FluoroCouncil, ignored FDA scientists’ study even though it was published ten months before the industry group submitted their analysis for peer-review. The peer reviewers appear to have missed the omission as well. As a result, the industry evaluations continue to perpetuate the flawed assumptions, concluding that perfluorohexanoic acid (PFHxA) and related short-chain PFAS “present negligible human health risk” and that this substance alone is a suitable marker for the “safety of fluorotelomer replacement chemistry.”

In this blog, we discuss the differences between the studies and the implications of the discordance between FDA’s and industry’s conclusions for the safety assessment of short-chain PFAS.

What do we know about short-chain PFAS?

With the phase-out of long-chain PFAS to make water- and grease-proof materials, companies shifted to short-chain fluorotelomer-based chemistry.[1] These new raw materials are used to build polymers and include chemicals that contain six fully-fluorinated carbon groups with additional non-fluorinated carbons. These molecules are usually known as C6 and a common starting material for polymers is a 6:2 fluorotelomer alcohol (6:2 FTOH) that has six fully-fluorinated carbons and two non-fluorinated carbons with an alcohol on the non-fluorinated end.

Industry expected that these C6 compounds, among them 6:2 FTOH and its main manufacturing impurity perfluorohexanoic acid (PFHxA), would: 1) be less toxic than long-chain PFAS such as 8:2 FTOH, PFOA and PFOS; and 2) not accumulate in the body.

However, these expectations do not hold up under scrutiny. A 2015 study by an FDA scientist concluded that “significant data gaps remain” about the toxicity of the 6:2 FTOH, and in the 2018 study, the agency scientists raised the potential for biopersistence.

FDA scientists’ thorough evaluation of publicly available[2] animal and human exposure data on 6:2 FTOH provided important insight into the body’s transformation of the chemical. They identified three metabolites, namely the PFHxA mentioned above, 5:3 fluorotelomer carboxylic acid (5:3 A) and perfluoroheptanoic acid (PFHpA) that could be used as markers of 6:2 FTOH exposure. For each metabolite, they also provided internal exposure estimates. The figure below shows 6:2 FTOH (in blue box) and how the body converts it to the three metabolites (in red boxes).

As a result of their analysis, FDA scientists identified 5:3 A as an important biomarker for the potential biopersistence of 6:2 FTOH because:

5:3 A had the highest internal exposure and the slowest elimination by the body; and

5:3 A’s elimination was reduced when exposure to 6:2 FTOH increased.

FDA’s scientists also concluded there are sex-based differences in the elimination of the other two metabolites, PFHxA and PFHpA, in animal studies. Although human data was only available in men, the difference observed in animals could mean that men and women may have different internal exposures and, therefore, experience different toxicity.

FluoroCouncil-funded reviews reached a different conclusion

In January 2019, two reviews (HERE and HERE) funded by the FluoroCouncil were published concluding that:

PFHxA “is less hazardous to human health than PFOA”;

“PFHxA and related fluorotelomer precursors currently appear to present negligible human health risk to the general population”; and

PFHxA is not expected to bioaccumulate due to its “rapid and nearly complete elimination” from the body.

These reviews evaluated the toxicology, exposure and biomonitoring data available for PFHxA. The analysis included the estimation of a toxicity reference dose and drinking water and residential groundwater screening levels. The overall conclusion was that “PFHxA levels currently present in the environment are well below levels that may present a concern for human health.”

The main difference between these reviews and the study by FDA scientists is that the industry-funded scientists focused exclusively on PFHxA. Their goal was to review the literature relevant to risk assessment to answer questions regarding “potential human health risks associated with exposure to fluorotelomer-based products” using PFHxA as a reference chemical for the entire short-chain PFAS class.

The two industry-funded reviews reported that PFHxA has been measured in water, soil, household dust, human serum, plasma, whole blood, urine, breast milk, and food with various frequencies. And that the substance is environmentally persistent, mobile and may accumulate in the leaves and fruits of plants. The reviews also reference a 2013 publication estimating that the mean half-life in humans is 32 days. In other words, it may take a month on average for half the amount present in the body to be eliminated.

Although the industry-funded reviews narrowly focused on a single chemical, the authors extended their conclusion to the entire fluorotelomer-based chemical process when they say that PFHxA is a “suitable marker for the safety of fluorotelomer replacement chemistry used today.” That is quite a bold statement that was not fully explained.

Following their reasoning, any other short-chain PFAS used in fluorotelomer-based products would be assumed to be as safe as PFHxA, including 6:2 FTOH. That assumption, however, appears to be flawed based on FDA scientists’ study showing that 6:2 FTOH metabolite 5:3 A is an important biomarker for the potential biopersistence of 6:2 fluorotelomer alcohol.

Conclusion

The study by FDA scientists has the potential to be a game changer in the safety assessment of short-chain PFAS. Based on their conclusions, safety studies must:

Assess how the body breaks down these chemicals and how fast they are eliminated; and

Be redesigned to account for biopersistence by including long-term exposures and exposures during development.

A decade ago, industry led us to believe that the new technology replacing toxic long-chain PFAS would be “more favorable” to human health and the environment. As a result, FDA has been approving short-chain fluorotelomer chemicals to make polymers for use in contact with food without information on the potential biopersistence of the chemicals themselves or their metabolites.

As we have noted in previous blogs, it is time to start making decisions on chemicals’ safety based on scientific evidence – not on assumptions. For PFAS, FDA needs to reassess the safety and environmental impacts of these chemicals for use as food contact substances. Until that review is complete, companies should avoid using products treated with the chemicals.

Today, Heidi Vogt at the Wall Street Journal reported on the systematic efforts by the Trump Administration to derail chemical assessments under the Environmental Protection Agency’s (EPA) Integrated Risk Information System (IRIS).

Decisions are being made as I write by conflicted EPA political appointees, not only to derail the beleaguered IRIS assessment for the carcinogen formaldehyde, but to transfer any further assessment of the chemical to be under the control of those same political appointees.

The WSJ article cites an upcoming report by Congress’ Government Accountability Office (GAO) that notes “EPA leadership in October directed the heads of the agency’s various programs to limit the number of chemicals they wanted IRIS to study or continue researching. Nine of 16 assessments were then dropped, including one that looked at whether exposure to formaldehyde increases the risk of leukemia that ‘has been drafted and is ready to be released for public comment.’ ” The chemical industry has long sought to undermine the findings of numerous governmental authorities that have identified the dangers posed by formaldehyde, one of the industry’s biggest cash cows.

IRIS itself has also long been a target of the chemical and allied industries, including those well represented by EPA political appointees who are now able to drive the assault on IRIS from inside the agency.

This post will provide more of the backstory to the WSJ’s excellent reporting. It reveals additional decisions being made as I write by conflicted political appointees, not only to derail the beleaguered IRIS assessment for formaldehyde, a known human carcinogen, but to transfer any further assessment of the chemical to be under the control of those same political appointees. What is happening here we believe is ripe for further investigation.

A brief history of IRIS and its formaldehyde assessment

IRIS, established in 1985, is situated within the science branch of EPA, the Office of Research and Development (ORD). That placement is intentional: ORD is not a regulatory branch, and placing IRIS there was intended to create an arms-length separation and a degree of independence from the EPA program offices that make regulatory decisions, decisions that necessarily consider more than science and can get caught up in political battles. As stated on EPA’s website:

The placement of the IRIS Program in ORD is intentional. It ensures that IRIS can develop impartial toxicity information independent of its use by EPA’s program and regional offices to set national standards and clean up hazardous sites.

The science IRIS does serves all parts of EPA – all of its program offices and its 10 EPA regions – where it is used to inform air and water pollution limits, waste site cleanup standards and other risk levels and regulatory actions. IRIS chemical hazard characterizations are also widely relied on by other federal agencies and other countries, as well as state and local governments (see this letter of support for IRIS from the Environmental Council of the States).

The IRIS assessment of formaldehyde has a long, convoluted, and contentious history that I will only touch on here before focusing on the latest chapter of this saga.

In 2011, the National Academy of Sciences (NAS) reviewed the assessment and issued a report quite critical of the assessment’s structure and its presentation and analysis of evidence, though not of its conclusions regarding formaldehyde’s hazards. The report made numerous recommendations for improving the assessment and the IRIS process. That report led EPA to undertake a major overhaul of IRIS, in addition to redoing its formaldehyde assessment.

In 2014, the NAS reviewed IRIS’ progress in implementing its recommendations, and issued a new report that gave the program high marks, noting it had made more progress at a faster pace than had been expected.

In April 2018, the NAS conducted yet another review of IRIS and again specifically assessed the extent to which EPA had made progress in responding to its earlier 2011 and 2014 recommendations, yielding yet another positive report. In response, ACC issued a press release claiming it knows better than the nation’s most august scientific body.

In January 2018, EPA’s IRIS report to Congress indicated that “IRIS plans to deliver an External Review of its Formaldehyde Assessment for public comment and peer review in FY18.”

Enter the Trump EPA

First let me introduce the main EPA players in this latest chapter, in addition to the Office of the Administrator:

Nancy Beck, Principal Deputy Assistant Administrator for the EPA Office of Chemical Safety and Pollution Prevention (OCSPP), which administers the Toxic Substances Control Act (TSCA). Beck came to EPA in April 2017 directly from a senior position at the American Chemistry Council (ACC), many of whose member companies are major producers and users of formaldehyde. While at ACC, one of Dr. Beck’s main activities was a sustained assault on the IRIS program on behalf of ACC members; e.g, see here and here.

David Dunlap, Deputy Assistant Administrator of ORD, who came to EPA in September 2018 directly from Koch Industries. Among other polluting companies, Koch owns the pulp and paper giant Georgia-Pacific, which is a major producer and user of formaldehyde.

Despite the fact that IRIS resides in ORD, Beck in OCSPP has been extensively involved in agency activities involving the IRIS program. As one measure of this, consider Dr. Beck’s calendar for the first 10 months she was at EPA, which was recently released in response to an EDF FOIA request. During that short time, Beck’s calendar shows 19 call or meeting entries involving IRIS.

Efforts last year by the Administration and EPA political appointees to defund IRIS (see last entry on p. 19), followed by a Senate majority appropriations bill that included language to dismantle IRIS entirely and relocate parts of it to OCSPP, were thwarted. The enacted FY18 appropriations bill continues to fund the IRIS program at FY17 levels and mandates that the program stay within ORD (see page 578).

Bear in mind that a draft of the revised IRIS formaldehyde assessment itself has been ready for review since the fall of 2017. In anticipation of its release for review, both chambers of Congress in reports accompanying the Consolidated Appropriations Act of 2017 directed EPA to contract with the NAS to conduct an external peer review of the revised IRIS assessment and they appropriated the needed funding.

Meanwhile, efforts were being ramped up to kill off the assessment entirely. The most recent IRIS multi-year agenda, which was released in December 2015, listed the formaldehyde assessment as in progress. And it remains listed on the IRIS Tracker, with its status noted (optimistically, it turns out) as “Step 4. Public Comment and External Peer Review.” But formaldehyde has now mysteriously disappeared from the most recent IRIS program outlook document (published December 19, 2018). What happened?

In August 2018, ORD initiated a process to identify EPA program office priorities for IRIS assessments (see response to question 117, here). David Dunlap, immediately upon his arrival at EPA from Koch Industries, oversaw the completion of that effort, which led to the December IRIS outlook document from which formaldehyde is absent. Dunlap then issued a prospectively applicable EPA recusal statement that includes a voluntary recusal from any matters related to the IRIS formaldehyde assessment, due to his deep conflicts of interest based on his prior employment. Miraculously, his recusal statement was dated the same day as the IRIS program outlook document.

EPA Acting Administrator Andrew Wheeler was asked about the status of the formaldehyde assessment in questions for the record submitted by Senator Ed Markey subsequent to Wheeler’s January 16, 2019, Senate Environmental and Public Works Committee’s hearing on his nomination to become EPA Administrator. In his response, Wheeler wrote (see responses to question 116, emphasis added):

Because IRIS assessments are major investments in both time and resources, in an August 10, 2018 Memorandum to Agency program offices I requested an update of top priorities for IRIS assessments. Formaldehyde was not identified as a top priority.

With this decision, Step 1 of the Trump EPA’s strategy on formaldehyde appears to have been completed. Now it’s onto Step 2.

Formaldehyde is expected to be resurrected as a top agency priority – but now under OCSPP’s control

On January 29, the American Chemistry Council (ACC) posted a public notice of a meeting it will hold on February 20. The meeting notice follows an ACC letter dated January 7, 2019, sent to “formaldehyde stakeholders” announcing the creation of a formaldehyde consortium to plan for the anticipated imminent proposal by EPA to designate formaldehyde as a “high-priority substance” under TSCA:

Importantly, in January 2019, EPA is expected to announce the next 20 chemical substances that will undergo review by its TSCA risk evaluation program. Based on EPA’s guidance for selecting chemicals for risk evaluation, formaldehyde is a prime candidate for selection by EPA as a high priority chemical in this next round of reviews due to its widespread use in the production of consumer products and its inclusion on EPA’s TSCA work plan.

While EPA’s announcement has been delayed in part by the government shutdown, it simply defies credulity that ACC would have scheduled such a meeting unless ACC at least knew about, if not had a hand in, EPA’s plan to propose to designate formaldehyde as a TSCA high-priority chemical.

ACC’s stated purpose for the meeting is to prepare “to engage with EPA on its formaldehyde risk evaluation activities” in order to “to ensure that formaldehyde remains a sustainable chemistry for use in various product applications.”

(Given that the ACC meeting notice was made public and addressed to “formaldehyde stakeholders,” EDF and other NGOs active in TSCA implementation and with high interest in formaldehyde RSVP’d for the meeting, as instructed in the meeting notice. Each of us quickly received an email from ACC indicating we were not welcome to attend the meeting.)

Should EPA finalize its high-priority designation, OCSPP will then initiate a risk evaluation of formaldehyde. Under normal circumstances, OCSPP could be expected to rely heavily on an IRIS assessment of a chemical in preparing its TSCA risk evaluation – rather than reinvent the wheel and waste precious EPA resources in duplicative efforts. But we are not facing normal circumstances.

To summarize, in the span of a few weeks, it appears we will move from EPA’s Acting Administrator declaring formaldehyde not to be a high priority for the agency – and on that basis halting the finalization of the IRIS assessment – to EPA declaring formaldehyde to be a high priority for the agency – thereby resurrecting assessment of the chemical, but now under the direction of political appointees with a long history of antagonism toward IRIS’ science and with conflicts of interests on this chemical.

Now that is a corrupt process.

It doesn’t have to end this way

It would be a shame if this travesty plays out as the first major decision made under the leadership of the newly appointed OCSPP Assistant Administrator Alexandra Dunn, who has suggested she is looking to set a new and more balanced course for TSCA implementation. It’s not too late to remedy the situation:

IRIS could be allowed to complete the formaldehyde assessment through regular order, promptly releasing the current draft for agency, public and NAS review.

Beck could step back into her lane at OCSPP and stop interfering with IRIS.

If OCSPP still decides to designate formaldehyde as a high-priority substance, it should certainly rely on the completed IRIS assessment in conducting its risk evaluation, rather than having conflicted political appointees redo to their own liking the science IRIS has already done.

Might this impending debacle instead be turned into an opportunity for the new EPA leadership to start to demonstrate it is not simply captive to narrow corporate interests and to reaffirm a commitment to the agency’s mission to be science-based and protect human health and the environment?

The first time I spoke at a conference about air pollution, the venue was right beside a daycare—a well-regarded chain, no doubt with significant waiting lists. But on the outside, the facility was steps from onramps to a bridge and a major highway, where horns blared and buses and trucks idled at the lights.

The pollution around this daycare was invisible, but because there is still so much we don’t know about air pollution, so were many of the risks.

As assistant professor at American University Claudia Persico recently told CityLab, “While there is a literature on how pollution affects prenatal and birth outcomes, there isn’t a lot of research on how typical levels of pollution affect kids who are already born.”

What we do know from innovative hyperlocal pollution mapping efforts is that air quality can be eight times worse at one end of the block than the other. And living at the more toxic end of the street can increase the risk of heart attack or death for the elderly by 40 percent.

But what if we could create traffic maps for air pollution throughout our cities? The sensor and AI revolutions make it possible, and the advent of instant everything and other competing demands on urban space make it necessary. Data analytics and visualization on air pollution and its solutions create unprecedented opportunities for environmental progress, if we get it right.

The power of seeing the invisible

The potential for applying data visualization to tackle air pollution was the focus of a recent “innovation salon” event in New York City. And what surprised me most was that we didn’t discuss data nearly as much as we discussed people.

Sure, we talked about data, to start. Data visualization can help describe observations about the natural world, such as weather patterns or migratory paths for birds. At their best, data platforms even help users to take action based on what they’re seeing, such as locating vacant plots of land or accessing resources to organize a community garden.

Here’s one way our emotional brain comes into play regarding data. At the innovation salon we discussed the importance of people helping to create the data that describes their world. We want to locate ourselves in the data – we immediately look for our home on a map. People already respond to these hyperlocal maps of pollution where they live, work and play in a highly personal, visceral way. Even more, people value and trust data if they participated in creating it. So imagine being able to look at a map of your neighborhood to determine the severity of pollution on your block, and knowing that you helped create insight into the risk for your family of an asthma attack. This is the power of the sensor and analytics revolution.

Further, imagine companies using this data to design, fund, and show impact of the commendable zero-emissions commitments they are making for their fleets. Advocates for clean air policies can demonstrate the value of cleaner technologies, and celebrate victories in reducing the health and economic burdens of air pollution in communities. And if the data shows a neighborhood that is exposed to dangerous chemicals or invisible gases—as many environmental justice communities are today—advocates can use this information to work directly with the biggest levers with the biggest influence, to drive immediate change.

Data visualization to spark meaningful change

At our salon meeting in New York, we noted that one of the most frequent applications of data and visualization in “smart city” systems is to improve the ease of finding parking, which I’ll admit can be difficult here in DC. It also causes pollution when cars circle around a neighborhood searching for a space.

Just fixing parking, however, leaves a lot of value on the table. For example, employers discriminate against people who live far from the job. What is the point of parking if employers won’t give you an interview in the first place? Economic mobility requires mobility, which is unpredictable and expensive in many cities. Many smart minds are investing in e-mobility technology and last mile solutions that connect shared and active transit to bus and rail.

What if we could use data visualization to help solve big challenges like safe transit access? Data and visualizations can demonstrate a shared vision of the future that inspires us to apply that uniquely human superpower, the ability to turn on a dime.

Over 11,000 concerned Americans have sent messages to Members of Congress over the last two weeks to urge EPA and OMB to protect workers – the population at most risk – from methylene chloride in paint strippers.

Today, EDF met with the White House Office of Management and Budget (OMB) about the Environmental Protection Agency’s (EPA) draft final rule on methylene chloride-based paint strippers. We urged the office to ensure the ban on methylene chloride-based paint and coating removers covers both consumer and most commercial uses – as the agency originally proposed.

Removing these deadly products from stores, workplaces, and homes is a critical step to protecting public health. Methylene chloride is acutely lethal. Exposure to the chemical has led to over 50 reported worker deaths since the mid-1980s, more than 40 of which are attributed to use of methylene chloride-based paint strippers. Many more deaths have likely gone unreported. The chemical is also associated with a host of other serious health effects, including neurotoxicity, cancer, and liver impairment.

Despite the facts that workers represent the vast majority of reported deaths and face the highest risks of other health effects, it appears that EPA is poised to finalize a rule that excludes a ban on commercial uses entirely – and will instead merely initiate a lengthy, uncertain process that may lead to certification and training approaches EPA had already considered and rejected as inadequate to protect workers.

During our meeting with OMB, we reiterated our full support for a ban on consumer uses, which is long overdue and absolutely necessary; but we urged that workers not be left behind. The key points we raised are the following:

EPA must act because it has already identified unreasonable risks. The evidence is overwhelming that methylene chloride-based paint and coating removers present unreasonable risks to both workers and consumers. In its 2014 risk assessment and 2017 proposed rule, EPA identified that the use of these products poses clear risks that are orders of magnitude higher than acceptable levels for both cancer and non-cancer health effects. EPA is legally obligated under TSCA to mitigate the unreasonable risks it has identified – to workers in addition to consumers.

A ban is the only option that provides sufficient protection. The record is clear that approaches short of a ban, such as certification and training programs, are not sufficient to address the risks to workers EPA identified. A simple ban on commercial uses of methylene chloride would also be far less costly, easier to implement, and more effective than risk management through a certification system or occupational respiratory protection program. EPA discussed and rejected both approaches in its proposed rule, due to their major limitations.

Without a commercial ban, EPA cannot fully prevent consumer use. EPA’s apparent bifurcation of its approaches to address consumer and commercial uses could still allow consumers to gain access to such products intended for commercial use.

TSCA only allows exemptions from restrictions needed to mitigate unreasonable risks for uses of a chemical that are critical or essential. The law provides no basis for EPA to exclude from restrictions any non-critical or non-essential uses – yet that appears to be what EPA is doing by excluding all commercial uses from the ban.

In the last two weeks, more than 11,000 concerned Americans have also voiced concern over any ban that leaves workers unprotected, by sending over 35,000 messages to their Members of Congress demanding that OMB and EPA finalize a ban covering both consumer and most commercial uses.

The health threat posed by methylene chloride in paint strippers to workers, consumers, and the general public isn’t up for debate. Or, at least, it shouldn’t be. EDF strongly urges EPA to finalize a ban that protects all Americans.

EDF study evaluates interactive online tools in three Ohio cities that help users know which addresses have a lead service line.

In 2016, EPA called upon states to work with drinking water utilities to make publicly available the location of lead service lines (LSLs, the lead pipes that connect the main under the street to buildings) via maps or other mechanisms. Ohio led the way with legislation requiring more than 1,800 utilities to submit static PDF maps that showed where LSLs were likely to be present and then posting the maps online. Three cities in the state took the effort a step further to communicate the information to their customers by posting online tools. In 2016, Cincinnati posted an interactive map of LSLs modeled after one posted by Washington, DC earlier that year. The next year, Columbus posted an interactive map and Cleveland posted a search engine enabling anyone to check the service line material at an address.

Interactive maps

Cincinnati Interactive Map, courtesy of Greater Cincinnati Water Works

The interactive map approach has become popular for displaying LSL locations. By our count, 16 communities in eight states now have them available online, with Illinois leading the way with six interactive maps – thanks to encouragement from the state. Every interactive map includes what is known or not known about the portion of the LSL on public property (commonly known as public- or city-side). However, only a few maps address the portion of the service line on private property (private-side). The maps also vary significantly in the icons they use, how they present what is unknown, and whether they encourage customers to provide information to update the map by submitting photos showing whether the service line is lead.

Interactive maps enable users to not only search a specific address but also quickly survey a neighborhood. In addition, people are familiar with them from our everyday life. However, users can easily misunderstand them by jumping right into the map, skipping through disclaimers that alert users of critical limitations and make assumptions about the meaning of the icons. Therefore, it is crucial that they are well-designed and user-tested.

EDF’s study

Given the diverse approaches taken to display LSL locations, EDF decided to conduct a study evaluating the online tools from three Ohio cities – Cleveland, Cincinnati, and Columbus – as examples to determine what features were most effective in prompting potential homebuyers or renters to replace the LSL, yet not become paralyzed by the health threat it poses. This effort involved a collaboration of EDF’s behavioral scientists (Rainer Romero and Sofia Hiltner) and its health program (Lindsay McCormick and Tom Neltner).

Today, AWWA Water Science published the peer-reviewed study. EDF’s key takeaways from the study are:

Online tools, including interactive maps and simple search engines, that allow anyone to search a specific address are an important way for communities to engage residents in accelerating LSL replacement, especially when searching for a new home to buy or rent.

When users discover that a property they wish to move into may have an LSL from an online tool, they overwhelmingly indicated they would be likely to pressure the seller to replace the LSL as a condition of purchase. Only 5% of survey participants said they would consider moving into a home without taking some action.

Users want information about both the city-side and private-side of the service line and may be frustrated when they learn a tool only provides information about one side.

How did we design our study?

In order to assess the comprehensibility of each tool, we surveyed 795 potential homebuyers and renters who currently live or have lived in Ohio. We chose this population because they could relate to the communities and were familiar with the homebuying or renting process.

All participants viewed the Cleveland Static Map at the beginning and the Cleveland Interactive Database (a search engine with no map feature) at the end. Half saw the Cincinnati Interactive Map and half saw the Columbus Interactive Map in between. We note that the survey could not test interactive features of these maps and instead used static images (like those pictured here). After viewing each tool, each participant responded to questions intended to assess whether they understood the information presented (i.e. whether an LSL was present on an individual property or in an area).

The survey also directed respondents to put themselves in the mindset of a potential homebuyer or renter who wished to move into a specific home. Next, they were informed whether an LSL was present or its status was unknown in the home. In each scenario, the survey asked them to select their likelihood of taking a specific action to replace the LSL or otherwise avoid lead exposure. Respondents were asked how likely they were to:

When asked which actions they would take if they (hypothetically) learned there was an LSL on a property that they wished to move into, participants overwhelmingly said that they would be likely to take action to either remove the LSL, or avoid it by looking for another home to move into. In fact, we saw that our respondents expressed greater willingness to take action on LSLs at home than respondents in studies where we asked about likelihood of taking action on other environmental issues (i.e., calling a state representative or city official about air quality issues or about the need for leak detection and repair in the natural gas distribution systems in cities). See the table below for our findings across the three interactive tools assessed.

Table: Likelihood of performing action in response to LSL-status*

Insist owner to confirm LSL-status

Insist owner replace LSL as condition of purchase or rental

Look for another home

Move in & pay for LSL replacement

Move in & leave LSL alone

Lead is present in either side of service line

--

85-91%

81-88%

33%

4-6%

Lead status is unknown

88-90%

--

55-65%

--

--

*Ranges are derived from various conditions. See the full article for more precise results.

Further, only one in four of potential renters indicated they would be likely to install a filter and replace it monthly at a loss of about $150 a year (only queried after viewing the Cleveland Interactive Database), demonstrating instead a preference to insist the landlord replace the LSL as a condition of rental or look for another home to rent.

Overall, the participants demonstrated the greatest understanding of the Cincinnati Interactive Map, which provided information about both the public and private-side of service lines at individual properties. Respondents were more likely to correctly report the LSL-status of a property on this map than when viewing the other tools. (See figure below for more information).

Figure: Comprehension of whether a tool presented information about the public or private side of the service line

While the Cincinnati Interactive Map was the preferred tool among those who viewed it, we found that those participants who instead viewed the Columbus interactive map preferred Cleveland’s Interactive Database. We think this could be because the Columbus Interactive Map had confusing legends and did not make as clear as the Cleveland Interactive Database that it did not include information on the private side. Note, however, that we specifically selected the Cleveland Interactive Database because it allows any user to view information on specific addresses, while most similar searchable databases are not readily usable by the public because they require a customer account number or phone number to access address-specific information.

Recommendations

What should communities consider when developing their own interactive tools?

Based on our findings, we provided the following recommendations for those looking to develop or improve interactive tools that provide information about LSLs. Please read the full article to see all of our recommendations described in detail.

Provide information about individual properties. Prospective home buyers and renters want to determine whether the property they are interested in may have an LSL. Furthermore, if a property owner replaces an LSL, a tool that does not provide property-level information will not reflect this action, potentially lessening the incentive for property owners to replace LSLs.

Provide information on the private side, in addition to the public side, of the service line. If the tool only provides information about the public-side, users may not be aware that the service line includes a private side as well. Further, if they later learn that the private-side is not included, they will be frustrated. We recommend that if a tool only provides information for the public side, it should be made very clear that 1) it refers to the public side, and 2) that a private side also exists. Beyond creating potential confusion, the absence of this information may also lessen the incentive for property owners to replace their private side LSLs.

Be explicit about what is not known. Our results demonstrate that participants found it useful to be informed if the service line material is unknown — and did not appear to be confused by such information. The most transparent approach is to explicitly indicate if service line material is unknown and update the map over time, as applicable.

Columbus Interactive Map, courtesy of Columbus Water

Carefully consider legends, colors, and icons. These features of a map can dramatically impact a user’s understanding of a map, and their subsequent behavior. For example, while we did not design the study in such a way to determine its impact definitively, we hypothesize that the use of a red X (which may have a negative connotation) in the Columbus interactive map (to the right) to denote that the LSL has been removed or is not in use (i.e., not lead), may have been the driver of lower comprehension we found for this particular map. See this ESIR presentation on best practices for map design as well as Color Brewer to test out map colors.

Complementing interactive maps with other communication and disclosure requirements

Communities cannot rely solely on interactive maps or tools to communicate the locations of LSLs. For example, only3.7% of our Ohio-based sample surveyed had previously heard about these types of online tools. Further, some users will inevitably misunderstand the tools. It is therefore critical not only to further advertise such tools to the public, but to reinforce this message through other communications, such as direct mailings and phone calls to property owners.

Another way of ensuring that prospective homebuyers and renters are aware of LSLs is by requiring the disclosure of the presence of an LSL during home sale and rental. While there is no federal requirement, currently seven states and Washington, DC require sellers to disclosure the presence of lead in plumbing to prospective homebuyers – and three cities (Cincinnati, Philadelphia, and now Washington, DC) require landlords to disclosure the presence of LSLs to tenants. Beyond these disclosure requirements, prospective buyers may also hire home inspectors to conduct a physical inspection for the presence of an LSL. Our team conducted a second study with a national sample in order to assess how potential homebuyers and renters would respond to the disclosure of such information when buying or renting a home. Stay tuned for further details.

Summary

Interactive online mapping and database tools with address-specific information on LSLs are a useful, although imperfect, way to effectively communicate to the public. Regardless of the tool used, providing people with information about the risks posed by the presence of LSLs is important. The widespread use of these tools should also provide an incentive for property owners to replace the LSLs when selling or renting property.

The Food and Drug Administration (FDA) has yet to decide three overlapping petitions requesting the agency take action on uses of ortho-phthalates in contact with food. Two of the petitions—a food additive petition and a citizen petition—were submitted by EDF, Earthjustice and nine other public health allies. In those petitions, we requested the revocation of all uses of this class of chemicals in food because the agency can no longer conclude that such use is safe. The law required FDA to make a decision by no later than September 2018; that deadline has long since come and gone, and the agency hasn’t acted.

The third petition was submitted by the Flexible Vinyl Alliance, an industry group. It requested that the agency revoke the food additive uses of 26 ortho-phthalates because, according to FDA’s notice, they had been abandoned. The agency agreed to review the petition in July 2018 and invited public comment on it in November 2018. Public comments were due on January 14, 2019.

In a press release about its petition, the industry group announced that only four ortho-phthalates “remain relevant in food contact applications”: di(2-ethylhexyl) phthalate (DEHP), diisononyl phthalate (DINP), dicyclohexyl phthalate (DCHP) and diisodecyl phthalate (DIDP). It also stated that it confidentially provided the agency with exposure and safety data on these four substances. The agency has made neither the industry’s petition nor the safety data on the four ortho-phthalates publicly available. We submitted a Freedom of Information Act (FOIA) request seeking industry’s “confidential” report and more information on the petition. We await a response.

What do the petitions from EDF and other public health advocates request?

In our petitions, we showed that ortho-phthalates are a class of chemically- and pharmacologically-related substances associated with reproductive, developmental, and endocrine health effects. We demonstrated that, when the cumulative effect of these chemicals in the diet are considered as required by law, the FDA cannot conclude their use as food contact substances (FCS) is safe. Given these health risks, we asked FDA to remove all food uses it had previously approved including those for paper, plastic, adhesives, coatings, and metal lubricants.

We also asked that FDA explicitly prohibit use of eight ortho-phthalates that an expert panel convened by the Consumer Product Safety Commission concluded were not safe to use in toys that children put in their mouths, reasoning that if the chemicals are not safe in such toys, they have no place in children’s food.

What does the industry claim in its petition?

The Flexible Vinyl Alliance’s food additive petition claims that some or all of the uses of 26 ortho-phthalates were permanently abandoned. If accepted by FDA, the petition would necessarily affect the cumulative risk assessment necessary to decide our pending food additive petition and our citizen petition. While it is a positive step that industry is abandoning uses of some of these endocrine disrupting chemicals, it was not a surprise.

Industry has taken a similar approach to our previous food additive petitions, seeking to moot parts of our petition and narrow the scope of the discussion. For instance, FDA accepted an abandonment petition on the use of styrene as a flavor while reviewing our carcinogenic flavors petition, enabling the industry to avoid a declaration by the agency that styrene was a carcinogen. For our perchlorate petition, FDA accepted another industry abandonment petition to narrow the focus of the exposure assessment.

Nine, not four, ortho-phthalates remain allowed for use in food contact materials

As we reviewed the FDA summary of the industry petition, we struggled to clearly understand what uses were covered. By comparing the list of ortho-phthalates in our petition to those the industry claimed were abandoned, we found that nine – not four – remain allowed for use. The nine are in the table below.

We were also disappointed to see that industry is actively using in food contact materials three ortho-phthalates banned from use in children’s toys by CPSC. It is a good example of regulatory dysfunction since CPSC’s expert panel determined that most of children’s exposure was from food.

The industry’s petition most likely did not address the use of DEP, DIOP, EPEG, and BPBG, and DEHP in plastics and polymers because the uses were sanctioned prior to 1958 and, therefore, technically they are not food additives due to a quirk in the law. The DAP use was most likely not addressed because the approval is for a chemical reacted to make another chemical and not added directly to food contact articles. However, as all of these uses remain approved, the agency must assume that they are ongoing. We made this point clear in our comments.

Furthermore, as we demonstrate in our petitions, exposure to any one of three of the ortho-phthalates that industry has not claimed to have abandoned (DEHP, DINP, or DIDP) is estimated to exceed the acceptable daily intake for ortho-phthalates. Logically, cumulative exposure to all nine ortho-phthalates exceeds this limit even if industry abandons some uses. The industry petition in no way lets FDA off the hook.

Many of the FDA-approved uses of ortho-phthalates involve food handling equipment such as conveyors, tubing, pumps, meters, tanks, chutes, and other equipment installed in facilities. Each of these uses may release ortho-phthalates into the food.

For a chemical use to qualify as abandoned, industry must not only cease to manufacture or sell the equipment containing it, but also no longer use any such existing equipment in contact with food. However, based on FDA’s Federal Register notice, the Flexible Vinyl Alliance appears not to have clearly demonstrated that the installed equipment containing ortho-phthalate-laden plastic was abandoned. This is important given the long life-expectancy of some types of food handling equipment.

In our comments, we raised this concern and advised FDA that if it accepts the abandonment claim, then any company using installed equipment containing ortho-phthalates that come in contact with food would be violating the law. We therefore requested that when publishing the final rule, FDA explicitly state that continued use of installed equipment with abandoned ortho-phthalates that come into contact with food is unlawful and the food processed with such equipment would be adulterated.

Alternately, FDA could narrow the abandonment claim to only future equipment. However, the agency must then continue to count the estimated migration of ortho-phthalates into food from each and every contact with the installed equipment as part of its evaluation of the safety of the remaining ortho-phthalates. This would mean that FDA cannot consider these uses to be abandoned.

FDA’s failure to share relevant documents with the public

FDA did not publish a copy of the Flexible Vinyl Alliance’s petition when it requested comment, most likely because the industry did not grant permission. This decision made it difficult to clearly understand how thorough or rigorous industry efforts were to confirm that uses were actually abandoned as it claimed.

In addition, FDA has not yet responded to our FOIA request for the industry’s “confidential” exposure and safety data that it submitted regarding the use of the four ortho-phthalates it considers relevant. Without that information, we are unable to evaluate the relevance to our petitions and make well-informed comments. In the comments we did submit, we state that both FDA and the industry must be more transparent with their documents and their analyses.

Once FDA agrees to consider a food additive petition like the one filed by the Flexible Vinyl Alliance or by EDF and its allies, the law directs the agency to publish a Federal Register notice within 30 days[1] and make a final decision within 180 days.[2] For the industry petition, the clock started on July 3, 2018, and a final decision was due on December 31, 2018. However, despite the law, FDA did not publish the notice until November 14, 2018 and the deadline for comments was January 14, 2018 – two weeks after the statutory deadline for action by FDA.

The delay in publishing the notice raises questions about the seriousness with which FDA takes these statutory deadlines. In our comments, we encouraged FDA to make timely decisions consistent with the statute.

Summary

In our petitions, we showed that ortho-phthalates as a class are not safe for use in food. Given the risks they pose, FDA has a duty to act. The first step is to make timely decisions – yet the agency is more than four months past due the September 2018 deadline.

To the extent that the Flexible Vinyl Alliance petition advances the agency’s decision on our petitions, we appreciate the effort. However, from what we can tell from the Federal Register notice, the industry appears to have underestimated the potential exposure from the remaining uses and left unresolved whether the abandonment includes ongoing uses in installed food handling equipment, and if not, how the agency intends to handle such uses.

Regardless of the effect of the industry petition on our efforts, it is certainly time for FDA to rule on whether to revoke its approval for all food contact uses of ortho-phthalates. The clock is ticking.

Washington, DC estimates there are 48,000 lead service lines (LSLs) on private property, 46 percent of the total number of service lines identified by the District. While the District has not yet set a goal of eliminating LSLs, it has taken positive steps to assist residents in replacing LSLs. It has prioritized avoiding partial LSL replacements, which are likely to increase residents’ exposure to lead, especially in the months following the disturbance.

Second, it redresses past partial LSL replacements by providing financial support to homeowners who did not replace the portion on private property when they were expected to shoulder the entire burden. This is the first city we have seen take this approach. The fiscal impact statement for the law also provides insight into the cost of LSL replacement; the District of Columbia Water and Sewer Authority (DC Water), the city’s utility, estimates the average cost to replace the portion on private property is $2,000 per line. The total cost of the law over four years if fully funded is $21 million.

Property owner disclosure to potential homebuyers and renters

DC Water has been a leader with its online, interactive map providing the public with access to what is known (and unknown) about service line plumbing material at individual properties. DC Water’s map has been a model for other communities, including Cincinnati, OH and Pittsburgh, PA.

The map is valuable in many situations to enable people to consider the risk of lead in their drinking water – from deciding on a home to rent or buy to evaluating a potential child care facility or even learning more about a restaurant. For those buying a home, the decision is a long-term commitment, where the customer has some leverage and could demand the cost of LSL replacement be folded into the sales price or mortgage. The map may also provide an incentive for property owners to proactively replace LSLs to avoid discouraging buyers or complicating the sales.

In the District’s new law, property owners renting residences must provide a “lead disclosure form” to the tenant before the person “is obligated under any contract to lease or renew the lease of the dwelling unit.” The form, to be developed by the District by April 2019, requires the property owner to disclose any known information:

Results of any lead tests conducted on the water supply of the property or the dwelling unit;

Lead-bearing plumbing, including an LSL serving the dwelling unit;

Whether the portion of the LSL on private or public property has been replaced, and, if so, the date of replacement;

Civil fines, penalties and fees imposed on the owner as sanctions for violating this disclosure requirement.

If a property owner learns of an LSL or other lead-bearing plumbing, the person must provide existing tenants within 48 hours with a completed copy of the new “lead disclosure form.” The District must also provide a means for tenants to report potential violations to appropriate agencies.

The new law adds similar responsibilities for property owners seeking to sell a home by amending an existing disclosure requirement. Using a new form to be developed by the District, the property owner must disclose the same information as in the first four items above, but not the part about civil fines, penalties and fees.

Under the law, the District will have three distinct programs to help replace LSLs. The first two are existing and updated by the law, and the third is new.

DC Water prompted replacement: If DC Water is disturbing or replacing the LSL on public property, it will also replace the portion on private property at no cost to the affected property owner. This usually occurs when the utility is replacing the main under the street, because the service line must be cut to perform the work.

Consent required: The only requirement to participate is that the property owner must affirmatively consent to the work. In most situations, the utility must notify the property owner at least twice and wait at least 120 days to consider silence as a refusal to consent to no-cost replacement. If the utility exceeds the lead action level, the 120 days is reduced to 60 days. If there is an emergency, the property owner is given a hand delivered notice and 24 hours to consent.

Funding required: The District estimates that it needs $1 million a year for this effort based on its current average of 500 LSLs replaced per year at $2,000 per line. If funding is not available, then the work won’t proceed unless the property owner refuses to consent to the work or pays for it.

Property owner prompted replacement: If the property owner alerts DC Water that it wants to replace the LSL, DC Water will replace the line on public property and coordinate the work on private property with the contractor at no cost. The property owner must pay only for replacement of the LSL portion on private property. Based on a colleague’s experience in 2017, DC Water has streamlined the process, and it cost her $1000 to replace the LSL on her row house.

Replacement of past partial replacement: For the 13,600 properties where DC Water replaced the LSL on public property but not on private property because the property owner was previously unwilling or unable to pay the cost, the District is now offering to pay the property owner between 50 and 100 percent of the contractor’s costs up to $2,500. The percentage is greater for low-income residents. Landlords are eligible if tenants participate in District or federal housing programs. The District estimates that it will cost $16.4 million over four years.

With the new law, the District and DC Water are taking significant steps to accelerate full LSL replacement in Washington, DC and taking a unique approach to addressing past partial replacements. We applaud the city and encourage it to join with the 53 communities who have already set a goal of eliminating LSLs.

]]>ACC to retailers, consumers, and the rest of us: You just don’t get that TSCA implementation is coming along swimminglyhttp://blogs.edf.org/health/2019/01/23/acc-to-retailers-consumers-and-the-rest-of-us-you-just-dont-get-that-tsca-implementation-is-coming-along-swimmingly/
Wed, 23 Jan 2019 17:19:37 +0000http://blogs.edf.org/health/?p=8422By Richard Denison

But in this era of alternative facts, the chemical industry says that’s because we’re all simply misinformed. And it’s taking steps to correct those alleged misperceptions.

The American Chemistry Council’s (ACC) agenda for its annual chemfest – called GlobalChem – is up online. One of the five plenary sessions for the two-day meeting in March is wholly devoted to the pressing need to figure out how the chemical industry can let everyone know just what a great success TSCA implementation has been:

According to ACC, the problem needing to be addressed is that “consumers, retailers, and other stakeholders may not be clear about the successes of TSCA implementation to this point.” And so it plans to solicit conference attendees’ input on: “What steps can we take to explain the successes to this point, and encourage a positive outlook for the future of TSCA?”

This – from an industry trade association that has spent the last two years grabbing all it can get from an Administration more than happy to give it what it wants. As to the balance and middle ground Congress sought to strike when it passed the Lautenberg Act in 2016? That is soooo 2016.

Far from being an innocent bystander, ACC has been a central actor in the industry’s effort to derail TSCA implementation. To cite just a few examples:

ACC demanded that EPA lower the fees Congress authorized it to charge industry to help defray the costs of TSCA implementation, which EPA had already significantly understated.

ACC steadfastly asserts that the 2016 amendments to TSCA made no significant changes to EPA’s reviews of new chemicals, despite massive evidence to the contrary. And it has relentlessly (and successfully) pressured EPA to scale back those reviews, the law be damned.

ACC abused an exemption it had secured in the new TSCA that removed a group of persistent, bioaccumulative and toxic (PBT) chemicals from expedited restrictions on the basis that they were being subject to expedited review as new chemicals. ACC is now demanding that EPA abandon that approach, start over, and instead review the chemicals under the procedures for review of existing chemicals under TSCA – delaying needed restrictions for many years.

I’ll grant ACC that, at least in the short term, TSCA implementation is succeeding in one respect – giving the chemical industry what it wants. Here are some of the policies the industry argued for that EPA has implemented:

EPA’s earlier proposed bans on high-risk uses of specific chemicals have either been abandoned or, in one case, delayed and scaled back;

EPA has not even hinted at using its expanded authority under TSCA to require companies to test, monitor for, or submit existing information on their chemicals – even as EPA declares chemicals with massive data gaps safe for any use;

EPA is denying public access to companies’ health and safety information in direct contravention of TSCA requirements;

EPA is ignoring major sources of exposure to chemicals when conducting risk evaluations, greatly decreasing the likelihood of determining there is risk that needs to be regulated;

EPA is no longer issuing orders imposing restrictions on or requiring testing of new chemicals, and will only rarely even require notification of reasonably foreseen uses;

EPA won’t address identified risks to workers, instead relying on provisions in new chemical notices and safety data sheets that impose no binding requirements on employers and shift the burden of protection onto workers;

there is little evidence EPA is reviewing industry claims for confidentiality in a timely and rigorous manner, and it has assigned the unique identifiers required under the law to only a fraction of chemicals whose identities are being withheld from the public; and

EPA is using methods for weighting scientific evidence that have never been peer-reviewed, deviate from established scientific practice, and are heavily biased toward industry studies.

For the chemical industry, what’s not to like? For the rest of us, not so much.

ACC’s session planners wonder “how TSCA could increase public confidence in chemical and product safety.” That will take a wholesale reset of the course of TSCA implementation towards health-protective regulation far beyond the wishful thinking in which ACC is engaging.

Yesterday Environmental Defense Fund (EDF) filed more than 100 pages of comments on a 40-page draft risk evaluation the Trump Administration’s Environmental Protection Agency (EPA) has prepared for Pigment Violet 29 (PV29). PV29 is the first of 10 chemicals undergoing risk evaluations under the Toxic Substances Control Act (TSCA). Our comments were so much longer than the EPA document we were commenting on because there was far more to say about what information EPA failed to obtain, make available or consider than what EPA included in its draft.

The essence of our lengthy comments can be boiled down to a single sentence, however: EPA has utterly failed to demonstrate that PV29 does not present unreasonable risk of injury to health or the environment.

For folks who want somewhat more detail than this, our comments start with a 4-page Executive Summary that capsulizes the many serious deficiencies we identified in EPA’s draft. I’ll provide some highlights in this post.

We have already blogged about several failures on EPA’s part:

EPA failed to provide public access to the 24 health and safety studies on which it relied, in violation of TSCA.

EPA relied on two acute inhalation toxicity studies to conclude no inhalation risk, despite the fact that the manufacturer that conducted the studies declared them “not reliable” due to use of an “unsuitable test system” and said the studies should be “disregarded due to major methodological deficiencies.”

EPA obtained a single, undocumented workplace air concentration value through a private personal communication with a conflicted industry source and used it as the basis to conclude that all workers and all other human populations face no significant inhalation exposure to PV29.

EPA concluded PV29 presents no risk to human health by combining that suspect inhalation exposure value with a toxicity value from a short-term oral toxicity screening test – despite the fact that internationally accepted (as well as EPA’s own) guidance cautioned that the results of that test cannot be used to conclude there are no adverse effects.

These failings are only the tip of the iceberg. I’ll mention 10 more flaws here that are detailed in our comments:

EPA fails to address the implications of the very high persistence of PV29 in the environment, and it lacks any measured data that directly assess the potential for PV29 to bioaccumulate in humans or other organisms; instead EPA uses modeled values derived from an estimation program that relies on insufficient data on similar chemicals.

EPA has no information on chronic aquatic toxicity, terrestrial toxicity, or toxicity to sediment-dwelling organisms, yet still draws the sweeping conclusion that PV29 presents no environmental hazard of any kind.

EPA has no actual data on the levels of PV29 released to or present in air, soil, sediment, surface water, people, other organisms, or products containing or made from the chemical.

EPA ignores all occupational exposures by downstream processors and users based on the false assumption that exposures would invariably be lower since they handle a smaller overall quantity of PV29 than the manufacturer.

EPA fails to analyze risk to consumers, the general public, and relevant subpopulations on the same basis, and uses an approach to sentinel exposure assessment that violates both scientific norms and EPA’s own regulation.

EPA lacks any data on absorption of PV29 by inhalation, dermal, and oral routes of exposure, yet concludes it cannot be absorbed.

For human health hazard, EPA relies on studies which mostly examined only acute lethal effects and none of which assessed chronic toxicity.

EPA dismisses the potential for increased adverse effects on susceptible subpopulations based on studies that failed to look for such effects.

EPA fails to include all necessary uncertainty factors—such as for extrapolating from acute to chronic toxicity values and for database deficiencies—in calculating its benchmark margins of exposure for worker inhalation and dermal exposures.

EPA has inconsistently and selectively applied its approach to systematic review, which has not been subject to any peer review and deviates from established, authoritative approaches to systematic review developed by experts.

EDF devoted such a high level of effort to this admittedly rather obscure chemical in part because PV29 is far from atypical in having so little information on its hazards and exposures. Indeed, similar data gaps apply to the large majority of chemicals falling under TSCA’s jurisdiction. A key aspect of the reforms to TSCA Congress made in 2016 was to enhance EPA’s authority to get the information it needed to conduct robust risk evaluations of chemicals in commerce. Yet under this Administration EPA has yet to even hint at using that authority.

The shoddiness of EPA’s draft risk evaluation of PV29 is a direct result of this failure.

For years, I have heard the chemical industry complain about the purported inadequacies of EPA science. Given that they’re essentially running the show at EPA these days, is what we’re seeing now what they had in mind as constituting sound science?